System, Nuclear Magnetic Resonance Imaging
Regulation 892.1000
28510(k)s in 12 months (1,110 all time)
60recalls in 12 months (723 all time)
630recalls that name a 510(k)
Top companies in LNH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 2, 2012 | Siemens Medical Solutions USA, Inc Siemens MAGNETOM Aera/Skyra, model numbers 10432914 and 10432915.
Nuclear magnetic resonance imaging system. Terminated |
LNH | K101347 |
| Nov 28, 2011 | Philips Medical Systems (Cleveland) Inc Ingenia 1.5T and 3.0T MRI Systems, Model Numbers: 781396 and 781377, 510(k) #K110151. System units equipped with software version: 4.1.1 are subject to recall/field correction.
This MRI system is Terminated |
LNH | K110151 |
| Oct 26, 2011 | GE Healthcare, LLC GE HEALTHCARE, MSK 1.5T EXTREME MR SCANNER, MODEL AA5000.
The MSK Extreme TM MR Scanner is intended for use as a diagnostic imaging device to produce axial, sagittal, coronal and oblique images of th Terminated |
LNH | K080048 |
| Sep 1, 2011 | GE Healthcare, LLC GE Healthcare, Discovery MR450
Product Usage: The Discovery MR450w is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam Terminated |
LNH | K083147 |
| Sep 1, 2011 | GE Healthcare, LLC GE Healthcare, 3.0T Signa MR750 (Marketing Name: GE Discovery MR750)
Product Usage: The GE Sigma MR750 System is a whole body magnetic resonance scanner designed to support high resolution and high Terminated |
LNH | K081028 |
| Sep 1, 2011 | GE Healthcare, LLC GE Healthcare, 1.5T Optima MR450w
Product Usage: The Optima MR450w is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam Terminated |
LNH | K091536 |
| Aug 10, 2011 | Siemens Medical Solutions USA, Inc MAGNETOM Aera/Skyra System - Nuclear magnetic resonance imaging Terminated |
LNH | K101347 |
| Jul 11, 2011 | Siemens Medical Solutions USA, Inc Siemens MAGNETOM Systems Symphony, Sonata and Symphony a TIM System
Nuclear magnetic resonance imaging system Terminated |
LNH | K993731 |
| Apr 18, 2011 | Siemens Medical Solutions USA, Inc MAGNETOM Avanto, Espree, Trio A Tim System.
Nuclear magnetic resonance imaging. Terminated |
LNH | K013586 K032428 +2 |
| Mar 1, 2011 | Philips Medical Systems North America Co. Phillips The Panorama HFO system has the Traceable Item Identification (12NC):
9896 030 17741-SW R 2.5.1 (shipped as R 2.5.1, upgraded to R 2.5.3 via FCO).
9896 030 19641-SW R 2.5.3
9896 030 19861-SW R 2.6.1
9 Terminated |
LNH | K041602 |
| Feb 24, 2011 | GE Healthcare, LLC 10) Brivo MR355/Optima MR360 Not yet 510(K) cleared and are not distributed in the US. (K103330)
The Brivo MR355/ Optima MR360 is a whole body magnetic resonance scanner designed to support high res Terminated |
LNH | K103330 |
| Feb 24, 2011 | GE Healthcare, LLC 9) Signa Excite 1.5 T (Excite II)
(K013636 Signa Infinity MR System with EXCITE Technology)
Signa Infinity MR System with EXCITE
(K013636 Signa Infinity MR System with EXCITE Technology)
The Terminated |
LNH | K013636 |
| Feb 24, 2011 | GE Healthcare, LLC 8) Signa 3.0T Infinity with EXCITE
(K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System)
Signa 3.0T with EXCITE
(K030874 GE 3.0T Signa Infinity TwinSpeed with EXCITE MR System)
The GE S Terminated |
LNH | K030874 |
| Feb 24, 2011 | GE Healthcare, LLC 7) Signa OpenSpeed
(K032795 GE 0.7T Signa OpenSpeed with EXCITE MR System)
The 0.7T Signa Openspeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support Terminated |
LNH | K032795 |
| Feb 24, 2011 | GE Healthcare, LLC 6) Signa Excite (K041476 Signa Excite 1.5T and 3.0T)
Signa Excite, 12x (K041476 Signa Excite 1.5T and 3.0T)
The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support h Terminated |
LNH | K041476 |
| Feb 24, 2011 | GE Healthcare, LLC 5) Signa HDx (K052293 Signa HDx and HDxt MR Systems)
Signa HDx or Signa HDxt (K052293 Signa HDx and HDxt MR Systems)
Signa HDxt (K052293 Signa HDx and HDxt MR Systems )
The GE Signa HD Terminated |
LNH | K052293 |
| Feb 24, 2011 | GE Healthcare, LLC 4) Signa HDe (K052978 GE 1.5T Signa HDe MR System)
The GE Signa HDe MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short Terminated |
LNH | K052978 |
| Feb 24, 2011 | GE Healthcare, LLC 3) Signa Advantage
(K911959 Signa Advantage MR System)
A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or Terminated |
LNH | K911959 |
| Feb 24, 2011 | GE Healthcare, LLC 2) Signa Advantage SP
(K942604 Signa Advantage SP MR System)
A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and Terminated |
LNH | K942604 |
| Feb 24, 2011 | GE Healthcare, LLC 1) Signa Lx
( K962061 Signa Horizon Cx)
The Signa Horizon Cx System is indicated for use as a diagnostic imaging device to produce transverse, saggital, coronal and oblique images of th Terminated |
LNH | K962061 |
| Feb 23, 2011 | Siemens Medical Solutions USA, Inc MAGNETOM Verio
Nuclear magnetic resonance imaging Terminated |
LNH | K072237 |
| Feb 18, 2011 | GE Healthcare, LLC GE Healthcare, Optima MR450w 1.5T MR systems
The GE Signa MR750 System is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. Terminated |
LNH | K091536 |
| Feb 18, 2011 | GE Healthcare, LLC GE Healthcare Discovery MR450 1.5T,
The Discovery MR450 is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It is indicat Terminated |
LNH | None listed |
| Feb 18, 2011 | GE Healthcare, LLC GE Healthcare Discovery MR750 3.0T
The GE Signa MR750 System is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The GE Si Terminated |
LNH | K081028 |
| Dec 21, 2010 | Philips Medical Systems North America Co. Phillips Accessory Cart for The ACHIEVA 3.0T and Panorama 1T Magnetic Resonance Imaging unit.
Consists of diagnostic devices that produce cross sectional images, spectroscopy images and/or spectra in any orie Terminated |
LNH | K031815 K041602 |
| Nov 26, 2010 | Philips Medical Systems North America Co. Phillips The product's marketing brochure states: "1.5T coils and accessories...Philips Achieva and Intera 1.5T MR systems".
The Identification of the Synergy Flex-M/ Shoulder Coil 1.5T can be found on the dr Terminated |
LNH | K001796 K031815 |
| Nov 24, 2010 | GE Healthcare, LLC Signa Excite" 1.5 T Magnetic Resonance Systems, manufactured by GE Healthcare, P.O. Box 44 Milwaukee, WI 53201. Terminated |
LNH | K013636 |
| Nov 19, 2010 | GE Healthcare, LLC Signa Ovation, 0.35T MR Systems (MFO 1-4).
Indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the musculoskeletal, vascular, cardiac, and Terminated |
LNH | K002611 K033504 |
| Nov 19, 2010 | GE Healthcare, LLC Signa OpenSpeed, 0.7T MR Systems (HFO3-5). Terminated |
LNH | K032795 |
| Sep 17, 2010 | Philips Medical Systems North America Co. Phillips Panorama 0.6T MRI Nuclear Magnetic Resonance Imaging System, Philips Panorama 0.6T Open MRI system, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143 Terminated |
LNH | K013858 |
| Sep 17, 2010 | Philips Medical Systems North America Co. Phillips Infinion is Nuclear Magnetic Resonance Imaging. Philips Infinion 1.5T System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.. Terminated |
LNH | K003853 K011296 |
| Sep 17, 2010 | Philips Medical Systems North America Co. Phillips Polaris, Nuclear Magnetic Resonance Imaging System, Magnet Subsystem, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.". Terminated |
LNH | K003853 K011296 |
| Sep 17, 2010 | Philips Medical Systems North America Co. Phillips Eclipse, Nuclear Magnetic Resonance Imaging system, Magnet Subsystem, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.". Terminated |
LNH | K964626 |
| Sep 17, 2010 | Philips Medical Systems North America Co. Phillips Vista Nuclear Magnetic Resonance Imaging System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.. Terminated |
LNH | K931544 K964626 |
| Sep 17, 2010 | Philips Medical Systems North America Co. Phillips Edge Nuclear Magnetic Resonance Imaging System. "1.5T Edge High-Field Magnetic Resonance Imaging System, Picker International, Inc. World Headquarters 595 Miner Road Cleveland, Ohio 44143, U.S.A.". Terminated |
LNH | K931544 K964626 |
| Aug 19, 2010 | Odin Medical Technologies Ltd. PoleStar FlexiCoil band D/E, revisions A and B, Catalog # 9733063,
Usage: Low field MRI device used to gather cranial images. Terminated |
LNH | K032541 |
| Feb 19, 2010 | Philips Medical Systems (Cleveland) Inc MRI Eclipse 1.5T System Model #781230.
The 1.5T Magnetic Resonance Imaging system intended for use with clinical/radiologic diagnostic imaging applications. Terminated |
LNH | K003853 |
| Jan 11, 2010 | GE Medical Systems, LLC Signa Excite 1.5T, Signa HD 1.5T, Signa HDx 1.5T, Signa HDxT 1.5T, Signa HDe, GE DISCOVERY MR450 and the Signa 3.0T MR750 MRI systems when used in conjunction with Confirma's CADstream (These systems Terminated |
LNH | K041476 K052293 +3 |
| Aug 25, 2009 | GE Medical Systems, LLC Signa Openspeed 0.7T MR Systems, Model Numbers:
Openspeed 3 (2138300-30), Openspeed 4 (2377062-5), Openspeed 5 (2377062-5, 2377062-30) Terminated |
LNH | K032795 |
| Aug 25, 2009 | GE Medical Systems, LLC GE Healthcare Signa Ovation 0.35T, Model Numbers:
Ovation 1-3 (2276937), Ovation 4 (2377062-2, 2377062-5, 2377062-8, or 5118172), and Ovation 5 (5148725).
The 0.35T Signa Ovation with Excite Magnetic Terminated |
LNH | K053009 |
| Jun 30, 2009 | GE Medical Systems, LLC GE Signa OpenSpeed 0.7T MR System.
The 0.7T Signa OpenSpeed with Excite Magnetic Resonance System is an open, whole body scanner designed to support improved higher resolution imaging and shorter sca Terminated |
LNH | K032795 |
| Jun 30, 2009 | GE Medical Systems, LLC GE Signa Ovation 0.35 T MR System.
The Signa Ovation System is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. Terminated |
LNH | K053009 |
| Jan 27, 2009 | iCAD, Inc. CAD SCIENCES LLC 3TP PrecisionPointTM Software, for biopsy guidance. Terminated |
LNH | None listed |
| Jan 27, 2009 | iCAD, Inc. CAD SCIENCES LLC 3TP TheraMapTM Software, for oncology treatment planning, assessment and monitoring of the patient response. Terminated |
LNH | K031350 K050862 |
| Sep 17, 2008 | GE Healthcare GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System The product is used as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or Terminated |
LNH | K041476 |
| Sep 17, 2008 | GE Healthcare GE 1.5T and 3.0T Signa HDx MR System The product is used as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of Terminated |
LNH | K052293 |
| Sep 16, 2008 | GE Healthcare GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System.
Model Numbers 5107849, 5107849-2, M3000PT, and M3000PW .
Indicated for use as a diagnostic imaging device to produce axial Terminated |
LNH | K041476 |
| Sep 16, 2008 | GE Healthcare GE 1.5T and 3.0T Signa HDx MR System
Model Numbers: 5127452, 2377062-61, and 2395001-2.
Indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectr Terminated |
LNH | K052293 |
| Sep 11, 2008 | GE Healthcare GE 1.5T and 3.0T Signa HDX MR System
Model Number(s): 2226300, 2377062-61, 2395001, 2395001-2, 5107849, and 5127452. This system is indicated for use as a diagnostic imaging device to produce axial Terminated |
LNH | K052293 |
| Sep 2, 2008 | Resonance Technology Inc Headset Model Number RTC-551-070 for use with the Serene Sound Digital MRI Compatible High Fidelity Stereo Sound System . Terminated |
LNH | K994351 |
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